Senior CQV Engineer

Job Summary

The Senior CQV Engineer leads commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment, facilities, utilities, automation systems, and infrastructure . This role ensures systems are designed, installed, tested, and maintained in compliance with cGMP and regulatory requirements while supporting capital projects, facility expansions, and operational readiness initiatives.

Responsibilities

• Lead CQV activities for GMP equipment, utilities, facilities, automation systems, and infrastructure.
• Develop and execute validation documentation, including plans, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and summary reports.
• Author, review, and approve SOPs, change controls, deviations, CAPAs, and validation lifecycle documents.
• Coordinate commissioning, startup, and qualification activities to support project timelines and operational readiness.
• Ensure compliance with cGMP, FDA, EU regulations, and data integrity requirements.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, Automation, Process Development) and external vendors.
• Support FATs, SATs, design reviews, construction walkdowns, and turnover documentation.
• Participate in audits and regulatory inspections as needed.
• Provide technical leadership, mentoring, and oversight to junior engineers and contractors.
• Support continuous improvement initiatives, risk reduction, and CQV process optimization.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field required.
• 6+ years of CQV experience in a GMP-regulated pharmaceutical, biotech, medical device, or life sciences environment.
• Strong knowledge of cGMP, FDA, EU regulations, and validation lifecycle principles.
• Experience leading CQV for GMP manufacturing equipment, utilities, facilities, and laboratory systems.
• Proficiency in writing and executing validation deliverables (IQ/OQ/PQ, risk assessments, traceability matrices, etc.).
• Experience supporting capital projects, equipment installations, and facility expansions.
• Knowledge of CSV, automation systems, and data integrity requirements preferred.
• Experience mentoring junior staff and collaborating across cross-functional teams.